Depression drug may be cleared for children

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http://news.independent.co.uk/uk/health/story.jsp?story=342090

Depression drug may be cleared for children

By Severin Carrell

13 October 2002

Children could soon be given the controversial anti-depressant drug Seroxat – despite evidence linking it to suicidal thoughts and mental problems in young teenagers.

In a move that will alarm the drug's critics, the British pharmaceuticals giant GlaxoSmithKline has asked for permission to market Seroxat to children in the United States. The application is expected to be followed by a similar bid in Europe.

Glaxo's decision comes despite evidence that its own clinical trials found that 10 per cent of depressed children who were given the drug endured serious psychiatric problems within weeks of using it.

Although the 93 children in the trial generally did better than those on an older drug or a placebo, five suffered suicidal thoughts, and five had other serious psychiatric problems. Many of the affected teenagers had to be sent to hospital.

These disclosures, to be made in a BBC Panorama documentary tonight, will deepen the controversy over the safety of Seroxat.

One of Britain's leading experts on anti-depressants, Dr Ian Healy, claims on Panorama that some doctors and psychiatrists are already giving children the drug, even though it is not officially approved for paediatric use.

The drug is now the world's second most popular anti-depressant, earning Glaxo £378m in European sales last year. Its critics allege Glaxo is keen to win approval to sell it for children partly because it will extend the patent giving it exclusive sales rights for a further six months.

The drug, sold in the US as Paxil, has been at the centre of a series of legal actions and claims that it causes suicidal tendencies, violence and depression among adult users.

Glaxo has already been ordered to pay one US family $6m (£3.9m) after a jury found that the drug led one 61-year-old man to kill his family of three and then himself by making him deranged.

But it won a major victory last week, when a judge in Los Angeles threw out one of the main charges against the drug, that it is also addictive.

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